In 2009, the Food and Drug Administration sent a “non-approval” letter to DePuy Orthapaedics indicating its application to sell a metal-on-metal hip implant device in the U.S. was being denied. The same letter asked the company to supply additional safety data if it wished to pursue approval of the device.
A year passed before the device in question, or its companion model were recalled by DePuy in August 2010. However, within weeks of the arrival of the 2009 letter, DePuy began to phase out the device, selling remaining stock of the implant for use in patients in this country and abroad.
The “articular surface replacement” implant was sold under the trademarked name ASR. Over a period of 8 years the two versions of this device were used in 93,000 patients around the world. About one-third of those patients live in the United States.
The ASR hip devices have been shown to fail prematurely at a rate three times that of the industry standard, but more disturbingly, the device sheds metallic debris as it wears, sending fragments into surrounding bone and tissue, with cobalt and chromium ions passing into the patient’s bloodstream.
Documents obtained by the New York Times and published in a report by Barry Meier on March 22, 2012 show that in 2009 DePuy knew that “high concentrations of metal ions” had been found in the blood work of some patients who received the ASR hip implants. Even after being informed of this fact by the FDA, however, the company continued to sell the hips as the product was phased out of production.
DePuy was also aware of the fact,, by mid-2009, that data collected in Australia showed the hips to fail within five years of implantation. The expected industry standard for an artificial hip’s working life is 15 years.
The company has consistently defended its position in selling off the remaining hips, insisting that the FDA’s letter merely indicated there was inadequate data “to evaluate the safety and effectiveness” of the devices.
In phasing out the device, DePuy executives started a program of “rationalization,” ending the production of the ASR device while selling off existing stock and persuading surgeons to switch to other DePuy manufactured implants.
There are currently thousands of hip replacement lawsuits in progress against DePuy with more on the way as the ASR devices fail in increasing numbers. The documents unearthed by the New York Times only seem to validate the assertion that DePuy not only knowingly left an unsafe device on the market, but liquidated remains stocks of that device with little thought to the safety of consumers.
As a DePuy hip recall lawyer, I understand the frustration that individuals that have experienced the premature failure of or other illnesses attributed to their hip implant must feel and encourage anyone affected by such an experience to contact a Harrisburg personal injury lawyer to discuss the possible legal options open to you.Tweet